Class II

Drug Recall: 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply

Novocol Pharmaceutical of Canada, Inc. · October 31, 2025

Reason for Recall

Defective container: cracked/broken cartridges

Product Description

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.

Distribution

U.S.A. Nationwide

States Affected

NATIONWIDE

Quantity Affected

18,789 cartons- 50 cartridges /carton

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0228-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.